The New England Journal of Medicine MAY 22, 2002

A Comparison of Rate Control and Rhythm Control in Patients with Recurrent Persistent Atrial Fibrillation (RACE)

Harry J.G.M. Crijns, Isabelle C. Van Gelder, et al.

Bottom Line

The RACE trial demonstrated that a rate-control strategy is non-inferior to a rhythm-control strategy for preventing cardiovascular morbidity and mortality in patients with recurrent persistent atrial fibrillation.

Key Findings

1. The primary composite endpoint occurred in 17.2% of patients in the rate-control arm compared to 22.6% in the rhythm-control arm, with an absolute difference of -5.4%, successfully meeting the prespecified criteria for non-inferiority.
2. Rhythm control was associated with a higher incidence of severe adverse effects of therapy (4.5%) compared to the rate-control group (0.8%).
3. There were no significant differences between the two treatment strategies regarding individual components of the primary endpoint, other than the increased rate of drug-related adverse events in the rhythm-control group.

Study Design

Design
RCT
Open-Label
Sample
522
Patients
Duration
2.3 yr
Median
Setting
Multicenter, Europe
Population Patients with recurrent persistent atrial fibrillation or flutter eligible for oral anticoagulation, with one or two previous electrical cardioversions.
Intervention Rhythm control strategy aiming for sinus rhythm using electrical cardioversion and sotalol prophylaxis.
Comparator Rate control strategy using beta-blockers, digoxin, or calcium-channel antagonists to maintain a resting heart rate <100 bpm.
Outcome Composite of cardiovascular death, hospitalization for heart failure, thromboembolic complications, severe bleeding, pacemaker implantation, and severe adverse effects of therapy.

Study Limitations

The trial specifically enrolled patients with recurrent persistent atrial fibrillation, potentially limiting the generalizability of these findings to other populations such as those with paroxysmal or long-standing permanent atrial fibrillation.
The use of sotalol as the primary rhythm-control agent may not reflect outcomes associated with more modern antiarrhythmic therapies or non-pharmacological interventions like catheter ablation.
The study was powered for a non-inferiority comparison, which may mask smaller potential benefits or harms of one strategy over the other.

Clinical Significance

The RACE trial provided essential evidence that rhythm control, which was historically favored, offered no morbidity or mortality advantage over a rate-control strategy for persistent atrial fibrillation, thereby establishing rate control as a valid, first-line management approach.

Historical Context

Prior to this trial, rhythm control was widely pursued with the assumption that maintaining sinus rhythm would improve patient outcomes despite the known risks of antiarrhythmic medications; RACE, along with the contemporary AFFIRM trial, fundamentally shifted clinical practice toward prioritizing symptom management via rate control.

Guided Discussion

High-yield insights from every perspective

Med Student
Medical Student

In the RACE trial, why is achieving 'rate control' considered a physiological priority even if the patient remains in atrial fibrillation (AF), and what are the specific risks of leaving a high ventricular rate untreated?

Key Response

High ventricular rates reduce diastolic filling time, leading to decreased cardiac output and potential heart failure (tachycardia-induced cardiomyopathy). The RACE trial emphasizes that controlling this rate is as effective for mortality and morbidity as attempting to restore sinus rhythm, provided the heart is protected from the deleterious effects of chronic tachycardia.

Resident
Resident

The RACE trial found that many thromboembolic events in the rhythm-control group occurred after anticoagulation was discontinued. Based on this finding and current guidelines, what determines the need for long-term anticoagulation in an AF patient who has been successfully cardioverted to sinus rhythm?

Key Response

The RACE trial highlighted that perceived sinus rhythm is not a guarantee against stroke, often due to subclinical AF recurrence. Therefore, current guidelines (AHA/ACC/HRS) dictate that anticoagulation should be based on the patient's stroke risk profile (CHA2DS2-VASc score), regardless of the perceived success of rhythm control or the clinical AF pattern.

Fellow
Fellow

The rhythm control strategy in the RACE trial primarily utilized serial electrical cardioversions and class I/III antiarrhythmic drugs. How do the trial's findings regarding the difficulty of maintaining sinus rhythm (only 39% at the end of the study) reflect the 'AF begets AF' hypothesis of atrial remodeling?

Key Response

RACE included patients with persistent AF, who often have significant structural and electrical remodeling (atrial fibrosis and ion channel changes). This substrate makes maintaining sinus rhythm via drugs difficult. This highlights the concept that once persistent AF is established, the substrate is often too advanced for traditional pharmacologic rhythm control to be consistently effective compared to simple rate control.

Attending
Attending

The RACE trial is often cited alongside AFFIRM to justify a 'rate-control first' approach. However, if you were to apply the RACE findings to a modern patient, how would the 'toxicities' of early-2000s rhythm control (e.g., side effects of amiodarone/sotalol) contrast with modern catheter ablation outcomes seen in trials like CABANA or EAST-AFNET 4?

Key Response

RACE's rhythm control arm was hampered by the proarrhythmic and organ-toxic effects of older antiarrhythmic drugs, which likely offset any benefit of sinus rhythm. Modern practice shifting toward catheter ablation offers a more 'durable' and less toxic rhythm control, which newer evidence suggests may improve outcomes if initiated early, unlike the late-stage rhythm control attempted in RACE.

Scholarly Review

Critical appraisal through the lens of expert reviewers and guideline development

PhD
PhD

The RACE trial was designed as a non-inferiority study with a composite primary endpoint. Given its relatively small sample size (n=522) compared to the AFFIRM trial (n=4060), evaluate the risk of a Type II error and the implications of the chosen non-inferiority margin on the study's conclusions.

Key Response

With only 522 patients, RACE was potentially underpowered to detect modest but clinically significant differences between groups. A large non-inferiority margin or a low event rate can lead to an 'absence of evidence' being misinterpreted as 'evidence of absence' of harm, requiring meta-analyses (which later confirmed these findings) to provide more robust statistical confidence.

Journal Editor
Journal Editor

A notable percentage of patients in the RACE rhythm-control group crossed over to the rate-control group due to treatment failure. As a reviewer, why would you insist on seeing both an Intention-to-Treat (ITT) and a Per-Protocol (PP) analysis for this non-inferiority trial?

Key Response

In superiority trials, ITT is conservative as it dilutes the effect of the intervention. However, in non-inferiority trials, ITT can be 'anti-conservative' because crossovers and non-compliance make the groups look more similar, artificially favoring a claim of non-inferiority. Comparing ITT and PP results is critical to ensure the non-inferiority conclusion is not merely an artifact of treatment crossover.

Guideline Committee
Guideline Committee

How did the RACE trial findings contribute to the shift in the Strength of Recommendation for rate control in persistent AF, and how do these recommendations reconcile the trial's results with the newer EAST-AFNET 4 data which favors early rhythm control?

Key Response

RACE and AFFIRM provided the Level A evidence that rate control is a primary, acceptable strategy (Class I recommendation) for many patients. However, current guidelines now emphasize 'Early' rhythm control for those with recent-onset AF, as RACE primarily looked at patients with recurrent, persistent AF where remodeling was already established. The guidelines now distinguish between the 'rate control' approach for established AF and 'early rhythm control' to prevent progression.

Clinical Landscape

Noteworthy Related Trials

2000

PIAF Trial

n = 252 · Lancet

Tested

Rhythm control strategy (amiodarone)

Population

Patients with persistent atrial fibrillation

Comparator

Rate control strategy (diltiazem)

Endpoint

Improvement in symptoms and exercise tolerance

Key result: Rhythm control did not improve symptoms or exercise tolerance more than rate control, and was associated with more adverse effects.
2002

AFFIRM Trial

n = 4,060 · NEJM

Tested

Rhythm control strategy

Population

Patients with atrial fibrillation at risk for stroke or death

Comparator

Rate control strategy

Endpoint

All-cause mortality

Key result: There was no significant difference in survival between rhythm control and rate control strategies.
2003

STAF Trial

n = 200 · J Am Coll Cardiol

Tested

Rhythm control strategy

Population

Patients with persistent atrial fibrillation

Comparator

Rate control strategy

Endpoint

Composite of death, cardiopulmonary resuscitation, stroke, and systemic embolism

Key result: No significant difference in the primary composite endpoint was observed between the two treatment strategies.

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